Inside a COVID-19 Vaccine Trial

S1: When I called up Dr. Cureton, like she’d set aside precisely 30 minutes for us to talk. She ended up giving me 38, but still she was in a hurry. Were you just doing vaccinations a couple hours ago?

S2: I was doing vaccinations of about one hundred and twenty seconds ago, actually, two minutes ago. And I just ran over from the vaccination area.

S1: Kirsten is running one of the corona virus vaccine trials that have cropped up around the country. Her labs at the University of Maryland. And this work, it’s not like any other experiment she’s run before. Her vaccines are at the very earliest phase of human testing. It’s called phase one.

S3: You know, straightforward phase one study is usually 40 people, 40, 50 people, 40 subjects or like 40 scientists, 40 to 50 subjects, volunteers who agreed to participate. And it may take anywhere from 12 to 18 months from the time we decide to do a study to ramp it up.

S4: How does that compare to what you’re doing now?

S3: So I can tell you that we got a call from Phi’s or roughly April 10th. Right. Right in that zone, requesting that we consider participation. And we had our first ZEW meeting that Wednesday is essentially two weeks of round clock work to get this study up and running. And to the point last week where we put out the call to volunteers asking for recruits.

S1: So are you saying that normally a process that could take, I don’t know, a year took four weeks.

S2: A month? Yeah. That’s exactly what I’m saying.

S1: Usually when you run an experiment, there is tons of red tape. There are ethical boards to consult, subjects to recruit. And you’ve got to convince other people. People with money that your research is important enough to move forward at all. Now, there’s none of that. Everyone agrees on the priority list. A vaccine against this novel coronavirus is at the very top of that list.

S3: People are working 24/7. We’re here every day of the week and everyone just feels like it’s so important that we have the opportunity to participate in something like this.

S1: I feel like I can hear the excitement in your voice.

S4: I feel I mean, it’s just it’s crazy.

S5: It feels like you’ve been waiting for this, like you’ve worked your whole life in the lab, but you’ve been, like, wanting to run.

S4: Yeah, it is kinda like that.

S5: When I called Kirsten up, this kind of optimism is not what I expected. She’s worked on vaccines for years. Some have panned out. Some haven’t. She knows trials like this one can take a long time. She also knows that the vaccine she’s testing might not work at all. So today on the show, why Dr. Kirsten, like, is optimistic anyway. She’s hoping she’s gonna have a vaccine in just a few short months. She’ll explain how in the world that’s even possible. I’m Mary Harris. You’re listening to what next? Stick with us.

S1: Can you describe the room where you’re giving the vaccinations? Like, do you have like a basement bunker?

S3: We have. I mean, it kind of just looks like your regular doctor’s office where we have several individual rooms where we can put one volunteer at a time. But these are really unusual times. So everyone that comes on to campus here in the state of Maryland has to wear a mask. And then we meet them at the door and we do a pre screening where we ask them if they’ve been exposed to kov it, if they’ve had Koven 19. And then we go through a list of questions to discern if they have any symptoms of Koban 19. And then we do their temperature and only then are they allowed. They get a little golden ticket, which is literally a little golden ticket that allows them to enter the vaccine area.

S4: It’s like Willy Wonka.

S3: This is Willy Wonka. Yeah, they love their golden ticket because they’re not they’re literally not allowed in without showing their their little yellow slip of paper. And then for vaccination, it’s a process. The very first thing that we do before we do anything else is we do a navel pharyngeal swab just like everyone around the country is getting to detect COBA 19. We do that here. So within 45 minutes, we’ve determined whether they’re shedding the virus and then only then if they’re negative, we can go ahead and we’ll randomize and enter them into the system so that we can get them on the docket for vaccination.

S1: It sounds like you feel like you’re on a clock.

S4: We are on a clock.

S3: We’re on Hoover on a very rapid sprint, which is over laying a marathon, because every single week we have to recruit a number of volunteers to fill our docket for next week’s dose escalation. So we’re vaccinating this particular round while simultaneously recruiting for next week’s round, where we’ll go to the next dose.

S1: How many vaccines a week are you giving?

S3: So we’re actually testing four different vaccines at three different dose levels. And then we’re also doing young people up to age 55. And then we’ll move to older people. So every one of those permutations needs fifteen people. This is just at this stage, a safety and immune study. We’re basically looking at immune responses and testing the safety of each of these permutations of vaccine. The overarching design of the study is to test people from age 18 to 85. Ultimately, with all sorts of risk factors for coalbed diabetes, hypertension, lung disease. But right now, in these very, very early stages, we’re testing just the 18 to fifty five year olds who are healthy. And then come June, we’ll move into the older age group and come July, we’re going to move into people who have other comorbid conditions. And as we work our way, you know, along the ladder, we’ll cover the full panoply of people who really, you know, are most at risk and need to have a vaccine.

S6: One of the things that’s helping for this particular scenario is that everyone is shut down. And at least at our center at the University of Maryland, we it’s called severe restriction. We’re not allowed to do other studies or invite other volunteers for any of our other ongoing studies. So it’s prioritized as COGAT 19 studies only.

S1: So this is all you can work on, like even if you wanted to work on other stuff.

S3: I mean, if there’s if there’s something that, you know, 20 years of research is going to go down, if they don’t continue, you know, that keeping their cell cultures in place, those are allowed to continue. There are dispensations, but for the most part, everything has been stalled. And anyone that has expertise in what we do is declared essential that we’re allowed to be on campus to continue our research. So that’s what’s happening here. Everyone has been freed up of their day to day work and everyone has time to concentrate on just doing this trial. I will say that we had a dry run with Ebola and I was lead investigator on the very first Ebola vaccine trial and that really there was a sense of urgency as well, because when we started, the first case in Dallas had just occurred. So there was a sense of urgency and that really taught us where we can cut bureaucratic corners while maintaining. All of the safety milestones and how we can ramp it up. And even that trial, like we learned a lot with that experience.

S1: How do you speed things up without cutting corners? Because even if you pour people into something, you know, it still takes a toll to move so fast.

S3: Yeah. So starting with this particular group of vaccines, obviously a 19 vaccine has not been in people and it not has not really been in a lot of we called preclinical studies. They go into different animals and they do exhaustive testing. So they did inject might they have some very limited data. But most of the data that was given to the FDA to move forward on this was with a companion vaccine that had been made with the same platform but aren’t necessarily covered 19 based vaccines.

S1: So it’s the same method, but it’s not the same virus.

S3: Right. So that may not fly in ordinary situations. But the FDA has agreed that the preponderance of evidence established that this was safe. We have safety data. But to some degree, it might not be the mountains of data that is typically generated before moving forward.

S1: What kind of people are volunteering for this? I mean, I know you pay them. So there’s like some incentive. But who’s showing up and saying, I want to be on the frontlines of testing a pretty unproven vaccine for Koven 19?

S3: Yeah, it’s it’s it’s interesting, right? Like who who who does this? The good thing is that there are a lot of people at home wanting to do something. Obviously there’s people at home that they need some money and we do compensate people for their time because they’re giving up their time to come here. But I would say overwhelmingly it’s not people looking for any compensation. Most people tell me they’re going to donate their their checks. It’s people from the community. It’s people that are associated maybe with the university but aren’t indirect patient care.

S1: And are you even really testing for how effective the vaccine is? Or is it mostly just safety? Because I know usually a phase one trial, which this is like just the beginning, you may look for a little bit of effectiveness, but you’re mostly just saying, like, can we do this?

S3: Right. So, yes, right now we’re interested predominantly in safety and also looking at the immune response and looking at whether the immune response that’s mounted is actually specific to the virus and can in a petri dish, basically. Is there neutralizing the antibodies? That’s how we term it overlying this. We are collecting data so that if they develop coded like symptoms, we’re going to have them do a self swab and send it to us so we can collect all of that data. And the length of the trial for the people participating right now is actually twenty six months, even though we hope we’ll have picked a vaccine and it’s gone into production well before that. You know, as early as this autumn, they’re still going to be participating and coming in for blood draws. So we can see how long that their antibody response last will have sort of a barometer of whether it’s protective, but it’s not powered to determine if it’s protective against Cobbett at this point.

S1: Like a lot of things when it comes to this coronavirus with this vaccine, we’re going to be learning a lot on the fly. Even if it’s proven safe and goes into production in the next few months, we might not know exactly how effective it is until after it gets released. There’s an element of taking it on faith here. What is effectiveness look like in a vaccine like this? Because I think we’re all used to I get the mumps vaccine, I get the chickenpox vaccine, and I don’t get that condition. I don’t get sick. Do you think we’re gonna be able to promise that with like a vaccine that we’re working on so quickly and a condition that we’re really just learning the contours of?

S3: Yeah, I mean, there are so many unknowns that it’s impossible to say. I can say this is what we hope for. We hope that Covered 19 is not mutating. We hope that the vaccine that we’re developing today is going to work next autumn, next fall, and that it’s going to cover people for a reasonable amount of time. And that is where what is reasonable to me may not be reasonable to someone else. So everyone has experience with the flu vaccine. And every year we have to make a new crop of. Means the vaccine may be 50 percent effective, 70 percent year by year. It’s very different. The total overall efficacy sometimes is zero percent effective, sometimes not very effective at all. And that would not be acceptable. I mean, we’re hoping for a high level of protective efficacy in a virus that’s not mutating. That’s a lot to ask. I mean, we just don’t know how this is going to all play out. All we know is that there are other current of viruses circulating. It’s the common cold. Over the decades, people just become immune. It doesn’t cause it deathly illness. And hopefully this will morph into that. But I don’t think we want to wait. You know, the amount of time that that takes for a society at large to develop immunity in her pre pandemic work.

S1: Dr. Kirsten, like, focused on diseases like Diné, which is caused by a virus and malaria, which is caused by a parasite. And the story of vaccine research for those illnesses, it just doesn’t have a happy ending, at least not yet. Those are conditions where we’ve been looking for a vaccine for years and not just looking like working. Working so hard. And we still haven’t found anything. Really?

S3: That’s absolutely correct. Yeah. And in half a million people die of malaria a year, and there is no sense of urgency anywhere up and down the levels of vaccine development.

S1: But it’s also like a tricky disease. I wonder if it kind of makes you humble going into looking at this coronavirus with folks saying, hey, in 18 months, we want to have a vaccine. You’ve you’ve been working for vaccines in plenty of viral conditions for a long time. And you know how hard the work is.

S3: Yeah, I mean, malaria is a different beast. This is very, very difficult to develop a vaccine because it’s so complicated. The beauty of viruses is they’re so simple, they can’t even replicate themselves. You know, it’s typically. HIV is an exception because it it morphs and it changes genetically, constantly evolving. So it’s very hard to keep up. But a bowl, for example, is such a simple virus and it can’t mutate that quickly because it typically ended up killing people before it has a chance to mutate. So it was relatively easy to make a vaccine. And we’re kind of hoping the same thing with covered. Not to minimize the difficulty.

S4: You sound so confident. Well, I think we are going to get it.

S3: I mean, there’s a hundred companies claiming that they have a vaccine and they want to bring it to fruition. We just happened to have been part of a process that had, you know, basically the financial means and the infrastructure to get it off the ground very quickly. So, yes, I hope this one works, but I also hope other vaccines work because by the time we get to autumn and start ramping up production, I don’t think one company is going to be able to develop worldwide mass production immediately. I’m not only counting that ours will work, but I’m really hoping that other vaccines will be successful as well.

S1: Yeah. One of the one of the things I read was that looking down the line, even if there is a vaccine that works. People are thinking we have a shortage of medical glass, which is what’s used to transport these vaccines around. Yeah. And so we have to ramp that up. Do you think we’re ready to do that?

S4: Well, I mean, we think a lot about that.

S3: How to do that. I’m personally don’t have time to think about it right now because we’re just trying to keep our heads above water and make sure we meet our quote of people who want to volunteer and continue to do this in a safe way because every single person is giving us blood. We’re looking at safety labs. We review things every night after work to make sure that everyone who’s lined up for tomorrow has safe labs, that everything looks good, that they’re not at risk.

S4: So, you know, when are you sleeping? Well, look, there’s not a whole lot.

S6: I have a son. He’s I had actually my best friend is taking care of my family right now because they just realized that’s not safe for me to be bringing home, you know, my possible exposure and and exposing my son. So my family’s in Philadelphia and I’m in Baltimore. Well, by Martin Amis.

S5: Detrich, Houston, like, thank you so much for talking to me.

S2: Oh, thanks so much for your interest, really. It was great to talk to you. And hopefully people will understand what we’re doing here and and and do their part by staying home.

S5: Dr. Carson, like is the lead investigator, Unkovic, 19 vaccine trials at the University of Maryland’s Center for Vaccine Development and Global Health. And that’s the show. What Next is produced by Daniel Hewitt, Jason de Leon and Mary Wilson. In this field, tomorrow will be what next? TBD with Lizzie O’Leary. She’s going to be talking to economist Emily Oster on how to deal with information overload. Thanks for listening. I’m Mary Harris. I will talk to you on Monday.

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